Fluid dispensing device

ABSTRACT

A fluid dispensing device is disclosed having a housing and a fluid discharge device. The fluid discharge device is arranged to be actuated by one or more levers so as to apply a force transversely to the fluid discharge device which is used to move a container forming part of the fluid discharge device along a longitudinal axis of the fluid discharge device to cause actuation of a pump forming part of the fluid discharge device. A pre-load means is used to prevent actuation of the pump until a pre-determined force is applied to each lever of sufficient magnitude to guarantee the production of a well developed efficient spray from the fluid dispensing device.

The present invention relates to a medicament dispenser and inparticular to a fluid dispensing device for use as a nasal inhaler.

It is known to provide a medicament dispenser, in which fluid spray isdispensed via a nozzle or orifice upon the application of a force by auser to an actuation lever or button. Such devices may be arranged todispense a single dose or may alternatively be arranged with a reservoircontaining several doses to be dispensed.

It is a problem with such a prior art sprays that if the actuator ismoved in a slow or unpredictable manner a strong and well defined spraymay not be produced and so the medicament may not be effectivelydispensed. This problem is particularly significant where an actuator(e.g. a lever) acts on a pump mechanism such as to pump the fluid to besprayed from a container. In this case, slow or unpredictable actuationresults in a slow or unpredictable actuation of the pump and hence, andunreliable spray characteristics. By way of a solution to this problem,the dispensing device herein includes a ‘commitment’ feature, whichprevents actuation of the pump in the absence of the application ofpre-determined force to a finger operable actuator.

It is an object of this invention to provide a fluid dispensing devicethat is easier to use and in particular a device which provides a moreefficient dispensing of fluid.

According to a first aspect of the invention there is provided a fluiddispensing device for spraying a fluid into a body cavity comprising ahousing, a nozzle for insertion into a body cavity, a fluid dischargedevice moveably housed within the housing, the fluid discharge devicehaving a longitudinal axis and comprising a container for storing thefluid to be dispensed and a compression pump having a suction inletlocated within the container and a discharge tube extending along thelongitudinal axis for transferring fluid from the pump to the nozzle andfinger operable means moveable transversely with respect to thelongitudinal axis of the fluid discharge device to apply a force to thecontainer to move the container along the longitudinal axis towards thenozzle so as to actuate the compression pump wherein a pre-load means isprovided to prevent actuation of the compression pump until apre-determined force is applied to the finger operable means.

The term finger operable means is meant to encompass such means operableby action of the finger or thumb, or combinations thereof of a typicaluser (e.g. an adult or child patient).

The finger operable means is moveable transversely with respect to thelongitudinal axis of the fluid discharge device to apply a forcedirectly or indirectly to the container. In alternative aspects, thefinger operable means may therefore contact the container or be coupledthereto to enable the necessary transfer of force.

Suitably, the finger operable means is arranged to apply mechanicaladvantage. That is to say, the finger operable means applies mechanicaladvantage to the user force to adjust (generally, to enhance or smooth)the force experienced by the container. The mechanical advantage may inone aspect, be provided in either a uniform manner such as by a constantmechanical advantage enhancement, for example by a ratio of from 1.5:1to 10:1 (enhanced force: initial force), more typically from 2:1 to 5:1.In another aspect, the mechanical advantage is applied in a non-constantmanner such as progressive increase or progressive decrease ofmechanical advantage over the applied force cycle. The exact profile ofmechanical advantage variation may be readily determined by reference tothe desired spray profile and all relevant characteristics of the deviceand formulation to be sprayed (e.g. viscosity and density).

Suitably, the finger operable means has a form, which naturally givesrise to mechanical advantage such as a lever, cam or screw form.

The finger operable means may comprise of at least one lever pivotallyconnected to part of the housing and arranged to transfer force to thecontainer (e.g. acting directly thereupon) so as to urge the containertowards the nozzle when the or each lever is moved by a user.

In one aspect, there are two opposing levers, each of which pivotallyconnect to part of the housing and may be arranged to act upon thecontainer so as to urge the container towards the nozzle when the twolevers are squeezed together by a user.

Alternatively, the finger operable means may comprise of at least onelever to apply a force to an actuating means used to move the containertowards the nozzle so as to actuate the pump.

In which case the or each lever may be pivotally supported at a lowerend within the housing and the actuating means may in aspects beconnected to a neck of the container (e.g. formed as a collar thereto).

Suitably, there may be two opposing levers, each of which is pivotallysupported near a lower end of the housing and may be arranged to actupon the actuating means so as to urge the container towards the nozzlewhen the two levers are squeezed together by a user.

Alternatively, the finger operable means may comprise of at least onelever slidably supported within the housing to apply a force to thecontainer so as to move the container towards the nozzle and actuate thecompression pump.

The pre-load means acts such as to prevent actuation of the compressionpump until a pre-determined force is applied to the finger operablemeans. The pre-determined force may thus, be thought of as a ‘threshold’or ‘barrier’ force which must first be overcome before actuation of thecompression pump can occur.

The quantum of pre-determined force that is to be overcome beforeactuation of the compression pump is enabled is selected according tovarious factors including characteristics of the pump, typical userprofile, nature of the fluid and the desired spray characteristics.

Typically, the pre-determined force is in the range from 5 to 30N, moretypically from 10 to 25N. That is to say, typically from 5 to 30N, moretypically from 10 to 25N of force must be applied to the finger operablemeans before actuation of the compression pump is enabled. Such valuestend to correspond to a force which prevents a suitable ‘barrier force’to a weak, nondescript or unintended finger movement whilst readilybeing overcome by the determined finger (or thumb) action of a user. Itwill be appreciated that if the device is designed for use by a child orelderly patient it may have a lower pre-determined force than thatdesigned for adult usage.

In accordance with a first embodiment of the invention the pre-loadmeans is physically interposed between the or each finger operable means(e.g. lever) and the container.

In which case, the pre-load means may comprise of a step formed on thecontainer which must be ridden over by the or each lever before thecompression pump can be actuated wherein the step is over-ridden whenthe pre-determined force is applied to the or each lever.

Alternatively, the pre-load means may comprise of a step formed on theor each finger operable means (e.g. lever) which must be ridden over bythe container before the compression pump can be actuated wherein thestep is over-ridden when the pre-determined force is applied to the oreach lever.

In yet a further alternative, the pre-load means may comprise of atleast one detent formed on one of the container or the or each fingeroperable means (e.g. a lever) and a recess formed on the other of thecontainer or the or each lever wherein the or each detent is able toride out of the recess with which it is engaged when the pre-determinedforce is applied to the or each lever.

According to a second embodiment of the invention the pre-load means isinterposed between the housing and the container.

In which case, the pre-load means may comprise of one or more detentsformed on the container for engagement with part of the housing, the orall of the detents being disengageable from the housing when thepre-determined force is applied to the finger operable means so as toallow the compression pump to be actuated.

Alternatively, the pre-load means may comprise of one or more detentsformed on the housing for engagement with part of the container, the orall of the detents being disengageable from the container when thepre-determined force is applied to the finger operable means so as toallow the compression pump to be actuated.

According to a third embodiment of the invention the pre-load means isinterposed between the container and the discharge tube.

In which case, the pre-load means may comprises of a step formed on thedischarge tube and at least one latching member attached to thecontainer, the arrangement being such that, when the pre-determinedforce is applied to the finger operable means, the or each latchingmember is able to ride over the step so as to allow the compression pumpto be actuated.

Alternatively, the pre-load means may comprise of a recess formed on thedischarge tube and at least one latching member attached to thecontainer, the arrangement being such that, when the pre-determinedforce is applied to the finger operable means, the or each latchingmember is able to ride out of the recess so as to allow the compressionpump to be actuated.

According to a fourth embodiment of the invention the pre-load means isinterposed between the housing and the or each finger operable means(e.g. lever).

In which case, the pre-load means may comprise of at least one detentformed on the housing for engagement with each lever, the or all of thedetents being disengageable from the respective lever when thepre-determined force is applied to the or each lever so as to allow thecompression pump to be actuated.

Alternatively, the pre-load means may comprise of at least one detentformed on each lever for engagement with part of the housing, the or allof the detents being disengageable from the housing when thepre-determined force is applied to the or each lever so as to allow thecompression pump to be actuated.

According to a fifth embodiment of the invention the pre-load means isinterposed between the actuating means and the housing.

In which case, the pre-load means may comprise of at least one detentformed on part of the actuating means for engagement with part of thehousing, the or all of the detents being disengageable from the housingwhen the pre-determined force is applied to the or each finger operablemeans (e.g. lever) so as to allow the compression pump to be actuated.

Alternatively, the pre-load means may comprise of at least one detentformed on part of the housing each detent being arranged for engagementwith a complementary recess formed on part of the actuating means, eachdetent being disengageable from its respective recess when thepre-determined force is applied to the or each finger operable means(e.g. lever) so as to allow the compression pump to be actuated.

According to a sixth embodiment of the invention the pre-load means isinterposed between the or each finger operable means (e.g. lever) andthe respective actuating means.

In which case, the pre-load means may comprise of at least one detentformed on the or each lever for engagement with a respective recessformed on part of the actuating means, each detent being disengageablefrom its respective complementary recess when the pre-determined forceis applied to the lever so as to allow the compression pump to beactuated.

Alternatively, the pre-load means comprises of at least one detentformed on each actuating means for engagement with a recess formed on arespective lever, each detent being disengageable from its respectivecomplementary recess when the pre-determined force is applied to thelever so as to allow the compression pump to be actuated.

As yet a further alternative, the pre-load means may comprise of anactuating device having a variable mechanical ratio such that until thepre-determined force is applied to the or each finger operable means(e.g. a lever) no significant force is transferred to the containeralong the longitudinal axis.

The fluid dispensing device may alternatively comprise of a fingeroperable means in the form of a single lever and the pre-load means mayfurther comprise of a spring interposed between the lever and thecontainer, the spring being used to urge the container towards thenozzle so as to actuate the compression pump.

In which case the spring may be compressed by movement of the leveruntil the pre-determined force is applied (i.e. by a combination ofuser-applied force and stored spring force), at which point thethreshold of the pre-load means used to prevent actuation of thecompression pump is overcome by the force being applied to the containersuch that the container moves rapidly towards the nozzle so as toactuate the compression pump.

Suitably, the fluid dispensing device is additionally provided withforce modifying means for modifying the force applied to the container.That is to say, means for modifying the force applied to (and therefore,ultimately acting on) the container compared to that force directlyapplied to the finger operable means by the user.

Suitably, the force modifying means acts such as to amplify the forceapplied (i.e. it comprises force amplifying means). The amplificationmay be provided in either a uniform manner such as by a constantamplification, for example by a ratio of from 1.5:1 to 10:1 (amplifiedforce: initial force; i.e. degree of amplification of from 1.5 to 10),more typically from 2:1 to 5:1. In another aspect, the amplification isapplied in a non-constant manner such as progressive increase orprogressive decrease of mechanical advantage over the applied forcecycle.

The exact profile of force modification may be readily determined byreference to the desired spray profile and all relevant characteristicsof the device and formulation to be sprayed (e.g. viscosity anddensity).

The force modifying means may in one aspect, be integral with the fingeroperable means. In this aspect, the force modifying means may comprisean aspect of the finger operable means shaped to give rise to amechanical advantage (e.g. a lever, cam or screw feature).

In another aspect, the force modifying means is located non-integralwith the finger operable means, and typically between the fingeroperable means and the container. Again this aspect, the force modifyingmeans may comprise an aspect of the finger operable means shaped to giverise to a mechanical advantage (e.g. a lever, cam or screw feature).

In one aspect, the force modifying means only acts (i.e. only acts tomodify the user applied force) once the pre-determined force has beenovercome. In preferred aspects, the modifying force acts such that oncethe pre-determined force has been overcome the force applied to thecontainer is either relatively constant or increases on a relativelyconstant basis.

In one particular aspect, the force modifying means additionallycomprises a stop feature, which acts to stop force being applied to thecontainer once either a particular maximum force is reached or moretypically, once the container has been moved a particular distance. Inone aspect, the stop functions to prevent excess force being applied tothe compression pump.

Embodiments are envisaged in which the fluid discharge device isreversibly removable from the housing of the fluid dispensing device. Insuch embodiments the fluid discharge device comprises a housing assemblyand fluid discharge device receivable thereby.

According to another aspect of the present invention there is thereforeprovided a housing assembly for reversible receipt of a fluid dischargedevice for spraying a fluid into a body cavity, said fluid dischargedevice having a longitudinal axis and comprising a container for storingthe fluid to be dispensed and a compression pump having a suction inletlocated within the container and a discharge tube extending along thelongitudinal axis for transferring fluid from the pump to the nozzle,the housing assembly comprising a housing, a nozzle for insertion into abody cavity and finger operable means moveable transversely with respectto the longitudinal axis of the fluid discharge device to apply a forceto the container to move the container along the longitudinal axistowards the nozzle so as to actuate the compression pump wherein apre-load means is provided to prevent actuation of the compression pumpuntil a pre-determined force is applied to the finger operable means.

According to a still further aspect of the present invention there isprovided a kit of parts comprising a housing assembly as described aboveand a fluid discharge device receivable thereby. The fluid dischargedevice has a longitudinal axis and comprises a container for storing thefluid to be dispensed and a compression pump having a suction inletlocated within the container and a discharge tube extending along thelongitudinal axis for transferring fluid from the pump to the nozzle.

Suitably, the fluid discharge device herein comprises a pre-compressionpump, such as a VP3, VP7 or modifications, model manufactured by ValoisSA. Typically, such pre-compression pumps are typically used with abottle (glass or plastic) container capable of holding 8-50 ml of aformulation. Each spray will typically deliver 50-100 μl of such aformulation and the device is therefore capable of providing at least100 metered doses.

It is also envisaged that the housing assembly could be supplied as aseparate item, into which a user or pharmacist later fits a suitablefluid discharge device.

The invention will now be described further with reference to theaccompanying drawing in which:—

FIG. 1 is a cross-section through a fluid dispensing device including afluid discharge device having a pre-load means according to a firstembodiment of the invention in a ready for use state;

FIG. 2 a is an enlarged view of the area indicated by the arrow ‘A’ onFIG. 1;

FIG. 2 b is an enlarged view similar to that shown in FIG. 2 a butshowing an alternative pre-load means;

FIG. 3 is a cross-section similar to that of FIG. 1 but showing thefluid dispensing device in use;

FIG. 4 is a cross-section similar to that shown in FIG. 1 but showing apre-load means according to a second embodiment of the invention;

FIG. 5 is an enlarged view of the area indicated by the arrow ‘B’ onFIG. 4;

FIG. 6 is a cross-section similar to that shown in FIG. 1 but showing apre-load means according to a third embodiment of the invention;

FIG. 7 is an enlarged view of the area indicated by the arrow ‘C’ onFIG. 6;

FIG. 8 is a side view in the direction of arrow ‘S’ on FIG. 7;

FIG. 9 is a cross-section of a fluid dispensing device having analternative mechanism to actuate the fluid discharge device to thatshown in FIG. 1 and having a pre-load means according to the secondembodiment of the invention;

FIG. 10 is a cross-section as shown in FIG. 9 but showing the mechanismused to actuate the fluid discharge device in an actuated position;

FIG. 11 is a cross-section of a fluid dispensing device having analternative mechanism to actuate the fluid discharge device to thatshown in FIG. 1 and having a pre-load means according to a fourthembodiment of the invention;

FIG. 12 is a plan view of the area indicated by the arrow ‘D’ on FIG.11;

FIG. 13 is a cross-section of a fluid dispensing device having analternative mechanism to actuate the fluid discharge device to thatshown in FIG. 1 and having a pre-load means according to a fifthembodiment of the invention;

FIG. 14 is a front view of a fluid dispensing device having analternative mechanism to actuate the fluid discharge device to thatshown in FIG. 1 and having a pre-load means according to the fourthembodiment of the invention with an end cap removed;

FIG. 15 is a front view of the fluid dispensing device shown in FIG. 14with an end cap in place;

FIG. 16 is an enlarged cross-section of the area indicated by the arrow‘E’ on FIG. 17;

FIG. 17 is a cross-section of a fluid dispensing device shown in FIG.14;

FIG. 18 is a cross-section of a fluid dispensing device having analternative mechanism to actuate the fluid discharge device to thatshown in FIG. 1 and having a pre-load means according to a sixthembodiment of the invention;

FIG. 19 is a cross-section that is similar to that shown in FIG. 18 butshowing an alternative pre-load means according to the sixth embodimentof the invention;

FIG. 19A is an enlarged side view of the collar occupying area indicatedby the arrow ‘J’ on FIG. 19;

FIG. 19B is an enlarged perspective view of the collar of FIG. 19B;

FIG. 20 is a front view of the fluid dispensing device shown in FIGS. 18and 19 but showing the use of a pre-load means according to the fourthembodiment of the invention;

FIG. 21 is a side view in the direction of the arrow ‘P’ on FIG. 20;

FIG. 22 is a cross-section of a fluid dispensing device having analternative mechanism to actuate the fluid discharge device to thatshown in FIG. 1 and having a pre-load means according to the secondembodiment of the invention;

FIG. 23 is a side view in the direction of arrow ‘T’ on FIG. 22; andFIG. 24 is cross-section of the area indicated by the arrow ‘F’ on FIG.22.

With reference to FIGS. 1, 2 a and 3 there is shown a fluid dispensingdevice 5 for spraying a fluid into a body cavity comprising a housing 9,a nozzle 11 for insertion into a body cavity, a fluid discharge device 8moveably housed within the housing 9, the fluid discharge device 9having a longitudinal axis and comprising a container 30 for storing thefluid to be dispensed and a compression pump having a suction inletlocated within the container 30 and a discharge tube 31 extending alongthe longitudinal axis for transferring fluid from the compression pumpto the nozzle 11 and finger operable means 20, 21 moveable transverselywith respect to the longitudinal axis of the fluid discharge device toapply a force to the container 30 to move the container 30 along thelongitudinal axis towards the nozzle 11 so as to actuate the compressionpump and a pre-load means 28 to prevent actuation of the compressionpump until a pre-determined force is applied to the finger operablemeans 20, 21.

The finger operable means is in the form of two opposing levers 20, 21each of which is pivotally connected to part of the housing 9 and isarranged to act upon a base portion 35 of the container 30 so as to urgethe container 30 towards the nozzle 11 when the two levers 20, 21 aresqueezed together by a user.

The fluid dispensing device 5 comprises of a plastic moulded body 6 andthe fluid discharge device 8 and further comprises of a protective endcap (not shown) having an inner surface for engagement with the body 6to protect the dispensing nozzle 11.

The body 6 is made from a plastic material such as polypropylene anddefines the housing 9 and the dispensing nozzle 11 so that the housing 9and the nozzle 11 are made as a single plastic component.

The housing 9 defines a cavity 10 formed by a front wall, a rear walland first and second end walls 14 a, 14 b. The dispensing nozzle 11 isconnected to one end of the housing 9, extends away from the housing 9and has an external tapering form.

The discharge outlet from the compression pump is in the form of thetubular delivery tube 31 and a tubular guide in the form of an outlettube 16 is formed within the nozzle 11 to align and locate the deliverytube 31 correctly with respect to the nozzle 11.

An annular abutment 17 is formed at the end of the outlet tube 16. Theannular abutment 17 defines the entry to an orifice 15 through whichfluid can flow in use and is arranged for abutment with an end of thedelivery tube 31.

The fluid discharge device 8 has a longitudinal axis X-X and each of thelevers 20, 21 has an abutment surface 22, 23 arranged at an angle θ tothe longitudinal axis X-X of the fluid discharge device 8 for abutmentagainst the base portion 35 of the container so as to convert a forceapplied to the levers 20, 21 substantially transversely to thelongitudinal axis X-X of the fluid discharge device 8 into a force alongthe longitudinal axis X-X of the fluid discharge device 8.

The nozzle 11 has a longitudinal axis that is aligned with thelongitudinal axis X-X of the fluid discharge device 8. This has theadvantage that when the compression pump is actuated the force appliedto the tubular delivery tube 31 is along the axis of the tubulardelivery tube 31 and no bending or deflection of the delivery tube 31will occur due to the applied force.

At least part of the surface of the base portion 35 of the container 30is inclined at an angle with respect to the longitudinal axis X-X of thefluid discharge device 8 so as to form an inclined surface, the or eachinclined surface being arranged to be acted upon by the levers 20, 21 soas to convert a force applied to the levers 20, 21 substantiallytransversely to the longitudinal axis X-X of the fluid discharge device8 into a force along the longitudinal axis X-X of the fluid dischargedevice 8.

Although in the disclosed embodiment both the levers and the containerhave surfaces inclined to the longitudinal axis of the fluid dischargedevice this need not be the case. Only the container or the levers needhave an inclined surface or some other arrangement to apply the forcefrom the levers to the container could be used.

The base portion 35 of the container 30 has two inclined surfaces 37, 38each arranged for co-operation with a respective one of the levers 20,21.

However it will be appreciated that the inclined surface of the baseportion of the container could be a conical, frusto-conical or partspherical surface.

The inclined surface 37 is arranged to co-operate with the abutmentsurface 22 and the inclined surface 38 is arranged to co-operate withthe abutment surface 23.

The abutment surface 22 is formed by an edge of a web 24 formed as partof the lever 20 and the abutment surface 23 is formed by an edge of aweb 25 formed as part of the lever 21.

In the arrangement shown in FIG. 2A, the pre-loading means is interposedbetween the levers 20, 21 and the container and as shown is in the formof small step 28 formed near to the end of each abutment surface 22, 23.In the ready for use position this lies against a side of the container30 at the juncture of the side of the container with the base portion35. The purpose of this step 28 is to prevent the levers 20, 21 frommoving the container 30 until more than a pre-determined force has beenapplied to the levers 20, 21.

The step 28 formed on each lever 20,21 must be ridden over by thecontainer 30 before the compression pump can be actuated. The step 28 isover-ridden when the pre-determined force is applied to each lever 20,21and once this pre-determined force is exceeded the pressure beingapplied to the levers 20, 21 is such that the container 30 is veryrapidly moved towards the nozzle 11. This prevents the levers 20, 21being slowly squeezed together which will not produce a uniform sprayand if done very slowly will merely cause the fluid to dribble out ofthe nozzle 11.

FIG. 2B shows an alternative arrangement in which the pre-load meanscomprises of a detent or protuberance 29 formed on the container 30 andcomplementary recess 27 formed on each lever 20,21. The size of thedetent 29 is such that they are able to ride out of the recess 27 whenthe pre-determined force is applied to each lever 20, 21. It will beappreciated that in other alternatives, the recess could be formed inthe container and the detent could be formed on the levers.

Each of the levers 20, 21 is pivotally connected to part of the housing9 by a respective living hinge. In the embodiment shown each of thelevers 20, 21 is pivotally connected to a respective one of the two sidewalls 14 a, 14 b by a respective living hinge 26 although other means ofpivotal connection could be used.

The fluid discharge device 8 is in most respects conventional and willonly be described briefly herein.

The fluid discharge device 8 has a hollow container 30 defining areservoir containing several doses of the fluid to be dispensed and thecompression pump that is attached to a neck 34 of the container 30.

The container 30 as shown is made from a translucent or transparentplastics material however it will be appreciate that it could be madefrom other translucent or transparent materials such as glass.

The compression pump includes a plunger (not shown) slidingly engagedwithin a pump casing that defines a chamber (not shown) sized toaccommodate a single dose of fluid. The plunger is attached to thetubular delivery tube 31 that is arranged to extend from one end of thepump for co-operation with the outlet tube 16 of the dispensing nozzle11. The plunger includes a piston (not shown) slidably supported in thechamber formed in the pump casing.

The fluid is discharged through a discharge channel defined by thetubular delivery tube 31 into the orifice 15 of the dispensing nozzle11.

The size of chamber is such that it accommodates a single dose of fluid,the diameter of the chamber and piston combined with the stroke of theplunger being such that a full stroke of the plunger in the chamber willproduce a change in volume equal to a single dose of fluid.

The pump casing is connected to the container 30 such that when thepiston is moved by a return spring of the pump (not shown) into a startposition a new dose of fluid is drawn into the cylinder via the suctioninlet in the form of a pick-up tube from the container 30 ready fordischarge.

Operation of the fluid dispensing device is as follows.

From the position shown in FIG. 1 in which the end portions of theabutment surfaces 22, 23 abut gently against the inclined surfaces 37,38 of the container 30 and the container 30 is abutting with the steps28 a user first grasps the fluid dispensing device 5 by the two levers20, 21. Provided that only a light pressure is applied to the levers 20,21 no fluid will be discharged and the user is able to manoeuvre thedispensing nozzle 11 of the fluid dispensing device 5 into the bodyorifice into which fluid is required to be dispensed. This is because ofthe presence of the pre-loading means formed in alternative embodiments,by the steps 28 of FIG. 2A or the detents/recesses 29, 27 arrangement ofFIG. 2B.

If the user then squeezes the two levers 20, 21 together with increasingforce the pre-determined force required to cause the container 30 toride up over the steps 28 (or detents/recesses 29, 27) will be attainedand the interaction of the abutment surfaces 22, 23 with the inclinedsurfaces 37, 38 will then cause the container 30 to be moved rapidlytowards the nozzle 11 as indicated by the arrow ‘M’ on FIG. 3.

However, the abutment between the end of the delivery tube 31 and theannular abutment 17 will prevent movement of the delivery tube 31 in thesame direction.

This effect of this is to cause the delivery tube 31 to push the plungerinto the pump casing thereby moving the piston of the pump in thecylinder. This movement causes fluid to be expelled from the cylinderinto the delivery tube 31. The fluid forced into the delivery tube isthen transferred into the orifice 15 from where it is expelled as a finespray into the body orifice.

Upon releasing the pressure applied to the levers 20, 21 the deliverytube 31 is urged out of the pump casing by the internal return springand causes fluid to be drawn up the pick-up tube to re-fill thecylinder. The container 30 will then be allowed to move back intoengagement with the steps 28 formed in the levers 20, 21 ready for thenext actuation of the fluid dispensing device 5.

The actuating procedure can then be repeated until all of the fluid inthe container has been used. However, only one or two doses of fluid arenormally administered at a time.

When the container is empty a new fluid discharge device 8 is loadedinto the housing 9 thereby restoring the fluid dispensing device 5 intoa useable condition.

With reference to FIGS. 4 and 5 there is shown a fluid dispensing devicethat is in most respects identical to that previously described and forwhich the same reference numerals are used for like components.

The primary difference between the fluid dispensing means shown in FIGS.1 to 3 and that shown in FIGS. 4 and 5 is that the fluid dispensingdevice 5 in FIGS. 4 and 5 uses a second embodiment of pre-load means inwhich the pre-load means 39, 40 is interposed between the housing 9 andthe container 30.

The pre-load means comprises of two detents 39, 40 formed on the housing9 for engagement with part of the container 30. The two detents 39, 40are disengageable from the container 30 when the pre-determined force isapplied to the finger operable means 20, 21 so as to allow thecompression pump to be actuated.

Each of the detents is in the form of an arm 39, which extendsdownwardly from the housing 9 for engagement with a corner of the neck34 of the container 30. A free end of each arm 39 has a step 40 formedtherein, which prior to actuation is in abutting contact with the neck34 of the container 30.

Operation of the fluid dispensing device is as follows.

From the position shown in FIG. 4 in which the end portions of theabutment surfaces 22, 23 abut gently against the inclined surfaces 37,38 of the container 30 and the container 30 is abutting with the steps40 a user first grasps the fluid dispensing device 5 by the two levers20, 21. Provided that only a light pressure is applied to the levers 20,21 no fluid will be discharged and the user is able to manoeuvre thedispensing nozzle 11 of the fluid dispensing device 5 into the bodyorifice into which fluid is required to be dispensed. This is because ofthe presence of the pre-loading means formed by the steps 40 and thearms 39 which prevent movement of the container towards the nozzle.

If the user then squeezes the two levers 20, 21 together with increasingforce the arms 39 will begin to bow outwardly until when thepre-determined force is reached the neck 34 of the container 30 is ableto disengaged itself from the steps 40 and the interaction of theabutment surfaces 22, 23 with the inclined surfaces 37, 38 will thencause the container 30 to be moved rapidly towards the nozzle 11.

However, as previously described the abutment between the end of thedelivery tube 31 and the annular abutment 17 will prevent movement ofthe delivery tube 31 in the same direction thereby causing thecompression pump to be actuated as the delivery tube 31 is pushed intothe container 30. This movement causes fluid to be expelled from thecontainer 30 into the delivery tube 31 and then into the orifice 15 fromwhere it is expelled as a fine spray into the body orifice.

Upon releasing the pressure applied to the levers 20, 21 the deliverytube 31 is urged out of the container 30 causing fluid to re-fill thepump. The container 30 will then move back into engagement with thesteps 40 formed in the arms 39 ready for the next actuation of the fluiddispensing device 5.

The actuating procedure can then be repeated until all of the fluid inthe container has been used. However, only one or two dose volumes offluid are normally administered at a time.

With reference to FIGS. 6 to 8 there is shown a fluid dispensing devicethat is in most respects identical to that previously described withrespect to FIGS. 1 to 3 and for which the same reference numerals areused for like components.

The primary difference between the fluid dispensing means shown in FIGS.1 to 3 and that shown in FIGS. 6 to 8 is that the fluid dispensingdevice 5 in FIGS. 6 to 8 uses a third embodiment of pre-load means inwhich the pre-load means 41, 42, 43 is interposed between the container30 and the discharge tube 31.

This embodiment has the advantage that it can be used irrespective ofthe mechanism used to actuate the pump.

The pre-load means comprises of a step 41 formed on the discharge tube31 and two latching members in the form of arms 42 attached by a collar43 to the neck 34 of the container 30. The step 41 is formed by a rib 44extending circumferentially around the discharge tube 31 and positionedsuch that when the pump is actuated the rib 44 does not prevent travelof the discharge tube 31 into the container 30.

The arrangement is such that, when the pre-determined force is appliedto the finger operable means in the form of the levers 20, 21, thelatching members or arms 42 are able to ride over the step 41 so as toallow the compression pump to be actuated but when a force below thepre-determined force is applied the interengagement of the arms 42 withthe step 41 prevents the discharge tube 31 from moving into thecontainer 30.

Operation of the fluid dispensing device is as previously described andprovided that only a light pressure is applied to the levers 20, 21 nofluid will be discharged and the user is able to manoeuvre thedispensing nozzle 11 of the fluid dispensing device 5 into the bodyorifice into which fluid is required to be dispensed. This is because ofthe presence of the pre-loading means formed by the step 41 and the arms42 which prevent movement of the container 30 towards the nozzle 11.

If the user then squeezes the two levers 20, 21 together with increasingforce the arms 42 will begin to bow until when the pre-determined forceis reached the arms 42 are able to disengage themselves from the step 41and the interaction of the abutment surfaces 22, 23 with the inclinedsurfaces 37, 38 will then cause the container 30 to be moved rapidlytowards the nozzle 11.

This movement causes fluid to be expelled from the container 30 into thedelivery tube 31 and then into the orifice 15 from where it is expelledas a fine spray into the body orifice.

Upon releasing the pressure applied to the levers 20, 21 the deliverytube 31 is urged out of the container 30 causing fluid to re-fill thepump. The container 30 will then move back allowing the arms 42 tore-engage with the step 41 ready for the next actuation of the fluiddispensing device 5.

The actuating procedure can then be repeated until all of the fluid inthe container has been used. However, only one or two doses of fluid arenormally administered at a time.

It will be appreciated that alternatively, the pre-load means maycomprise of a recess formed on the discharge tube 31 and at least onelatching member or arm attached to the container 30, the arrangementbeing such that, when the pre-determined force is applied to the fingeroperable means in the form of the levers 20, 21 the or each latchingmember is able to ride out of the recess so as to allow the compressionpump to be actuated.

With reference to FIGS. 9 and 10 there is shown a fluid dispensingdevice 105 which is in many respects similar to that previouslydescribed but instead of direct actuation of the fluid discharge deviceby the levers, the finger operable means in the form of two lever 120,121 are used to apply a force to an actuating means 122 a, 122 b; 132,132 a, 132 b used to move a container 30 towards a nozzle 111 so as toactuate the pump. For similar parts the same reference numerals will beused to those previously used in respect of FIGS. 1 to 3

The actuating means 122 a, 122 b, 132, 132 a, 132 b is connected to aneck 34 of the container 30.

The fluid dispensing device 105 for spraying a fluid into a body cavitycomprises a housing 9, a nozzle 11 for insertion into a body cavity anda fluid discharge device 8 moveably housed within the housing 9. Thefluid discharge device 8 comprises of a container 30 for storing thefluid to be dispensed and a compression pump having a suction inletlocated within the container 30 and a discharge outlet 31 at one end ofthe container 30 for transferring fluid from the pump to the nozzle 11.

A finger operable means in the form of the two levers 120, 121 isprovided to apply a force to the container 30 to move the container 30towards the nozzle 11 so as to actuate the pump.

The two opposing levers 120, 121 are pivotally supported within thehousing 9 and are driveably connected to the container 30 by means ofthe actuating means so as to urge the container 30 towards the nozzle 11when each lever 20, 21 is rotated by a user and in practice the twolevers 120, 121 are squeezed together by a user. That is to say,squeezing the two levers 120, 121 together causes the container 30 to bemoved towards the nozzle 11.

In more detail, the fluid dispensing device 5 comprises of a housingassembly and the fluid discharge device 8. The housing assemblycomprises of the housing 9 for moveably supporting the fluid dischargedevice 8, a body 6 having the nozzle 11 extending therefrom and the twolevers 120, 121 pivotally supported within the housing 9.

The body 6 and the nozzle 11 are made as a single part from a plasticmaterial such as polypropylene and the body 6 is adapted at a lower endfor engagement with an upper end of the housing 9. The body 6 and thehousing 9 are fixed together by any suitable means.

The housing 9 defines a cavity 10 formed by a front wall, a rear walland first and second end walls 14 a, 14 b.

The discharge outlet from the pump is in the form of a tubular deliverytube 31 and a tubular guide in the form of an outlet tube 16 is formedwithin the nozzle 11 to align and locate the delivery tube 31 correctlywith respect to the nozzle 11.

An annular abutment 17 is formed at the end of the outlet tube 16. Theannular abutment 17 defines the entry to an orifice 15 through whichfluid can flow in use and is arranged for abutment with an end of thedelivery tube 31.

The fluid discharge device 8 has a longitudinal axis co-incident with alongitudinal axis of the container 30 and a longitudinal axis of thetubular delivery tube 31. The nozzle 11 has a longitudinal axis which isaligned with the longitudinal axis of the fluid discharge device 8 sothat when the pump is actuated the force applied to the tubular deliverytube 31 is along the longitudinal axis of the tubular delivery tube 31and no bending or deflection of the delivery tube 31 will occur due tothe applied force.

Each of the first and second levers 120, 121 is driveably connected tothe container 30 near to said one end of the container 30 where thecontainer terminates in a neck 34.

To form the driveable connection each of the first and second levers120,121 has a pair of toothed portions 122 a, 122 b for engagement witha respective toothed rack 132 attached to the container 30 and inparticular to the neck portion 34 of the container 30. Each of the racks132 is arranged so as to extend parallel to the longitudinal axis of thecontainer 30.

Each of toothed racks 132 has two sets of opposed teeth, a first set ofteeth 132 a for engagement with the first lever 120 and a second set ofteeth 132 b for engagement with the second lever 121.

The neck portion 34 of the container 30 has a cylindrical outer surfaceand the two toothed racks 132 are arranged on opposite sides of the neckportion 34 so that the two toothed racks 132 are arranged diametricallyopposite with respect to the neck portion 34.

Each of the toothed racks 132 is connected to a collar 140 used toattach the toothed racks 132 to the neck portion 34 of the container 30.

It will be appreciated that the levers 120, 121 can be pivotallyattached to the housing 9 in any convenient manner or that each lever120, 121 could be pivotally supported within the housing 9 by a pivotalconnection between each lever 120, 121 and the body member 6.

The fluid discharge device 8 is as has previously been described andwill not be described again other than to mention that actuation of thepump occurs when the discharge tube 31 is pushed into the container 30.

The fluid dispensing device 105 is fitted with a pre-load meansaccording to the second embodiment of the invention, that is to say, thepre-load means 144 is interposed between the housing 9 and the container30.

The pre-load means comprises of a detent in the form of acircumferentially extending rib 144 formed on the container 30 forengagement with part of the housing 9. The rib 144 is arranged forengagement with two inwardly extending fingers 147 a, 147 b formed inthe side walls 14 a, 14 b of the housing 9. Each of the fingers 147 a,147 b is attached to the respective side wall 14 a, 14 b be a livinghinge such that movement of the fingers 147 a, 147 b towards the nozzleis prevented but pivoting of the fingers 147 a, 147 b relative to thehousing 9 is possible when they are urged away from the nozzle 11. Thisprovides a resistance to passage of the rib 144 if the container 30 ismoved towards the nozzle 11 but offers little to resistance to passageof the rib 144 if the container is moving away from the nozzle 11.

Therefore, the detent or rib 144 is disengageable from the housing 9 ormore specifically the fingers 147 a, 147 b when a pre-determined forceis applied to the finger operable means 120, 121 so as to allow thecompression pump to be actuated.

Operation of the fluid discharge device 105 is as follows.

First, a user must grasp the fluid dispensing device 105 by the twolevers 120, 121, provided that only a light pressure is applied to thelevers 120, 121 no fluid will be discharged due to the interactionbetween the rib 144 and the two fingers 147 a, 147 b and the user isable to manoeuvre the dispensing nozzle 11 of the fluid dispensingdevice 5 into the body orifice into which fluid is required to bedispensed. If the user then squeezes the two levers 120, 121 togetherwith increasing force eventually a pre-determined force will be reachedat which point the rib 144 is able to disengage with the housing 9 byriding over the fingers 147 a, 147 b and the interaction of the toothedportions 22 a, 22 b with the racks 32 will then cause the container 30to be moved rapidly towards the nozzle 11.

However, because the end of the delivery tube 31 is in abutting contactwith the annular abutment 17, the delivery tube 31 cannot move in thesame direction. The effect of this is to cause the delivery tube 31 tobe pushed into the container causing fluid to be expelled from thedelivery tube 31 into the orifice 15 from where it is expelled as a finespray into the body orifice.

At the end of the delivery stage when the fluid discharge device hasbeen discharged the two levers 120, 121 have been rotated so that theylie close to or flush with the side walls 14 a, 14 b as shown in FIG.10.

Upon releasing the pressure applied to the levers 120, 121 the deliverytube 31 is urged out of the pump casing by an internal return spring andcauses fluid to be drawn up to re-fill the pump.

The actuating procedure can then be repeated until all of the fluid inthe container has been used. However, only one or two volumes of fluidare normally administered at a time.

When the container is empty a new fluid discharge device 8 is loadedinto the housing 9 thereby restoring the fluid dispensing device 105into a useable condition.

With reference to FIGS. 11 and 12 there is shown a fluid dispensingdevice 165 which is in many respects similar to that shown in FIGS. 1 to3 but in which a single lever 170 is used to apply a force to anactuating means 176 used to move a container 130 towards a nozzle 111and actuate a compression pump. The lever 170 is pivotally supported ata lower end within a housing 109 and the actuating means 176 isconnected to a neck 129 of the container 130 by a collar 140.

The fluid dispensing device 165 is fitted with a fourth embodiment of apre-load means in which the pre-load means 150, 152, 153 is interposedbetween the housing 109 and the lever 170.

The pre-load means comprises of a detent in the form of a tooth 150formed on the housing 109 for engagement with the lever 170. The tooth150 is formed at the end of an arm 152 formed as an integral part of thehousing 109 and the lever 170 has a complementary rib 153 formed thereonfor engagement with the tooth 150.

The detent or tooth 150 is disengageable from the rib 153 on the lever170 when a pre-determined force is applied to the lever 170 so as toallow the compression pump to be actuated.

In more detail the fluid dispensing device 165 comprises of a bodystructure including the housing 109, the nozzle 111 extending out froman upper end of the housing 109 for insertion into a body cavity and afluid discharge device 108 moveably housed within the housing 109.

The fluid discharge device 108 comprises of the container 130 forstoring the fluid to be dispensed and the compression pump having asuction inlet located within the container 130 and a discharge outlet131 for transferring fluid from the pump to the nozzle 111.

The lever 170 is pivotally supported at a lower end within the housing109 and the actuating means is connected to the neck 129 of thecontainer 130 by a collar 140 engaged with the neck 129 of the container130.

The body structure comprises of a two-part plastic housing 109 and aplastic body member 106 both of which are moulded from a suitableplastic material such as polypropylene. The nozzle 111 is formed as anintegral part of the body member 106 and the body member 106 is fastenedto the housing 109 so that the nozzle 111 projects from the upper end ofthe housing 109.

The housing 109 has an aperture formed in a side wall 114 from which, inuse, a part of the lever 170 projects. The part of the lever 170 thatprojects from the aperture is a ribbed finger grip 146.

The discharge outlet from the pump is in the form of a tubular deliverytube 131 and a tubular guide in the form of an outlet tube 116 is formedwithin the nozzle 111 to align and locate the delivery tube 131correctly with respect to the nozzle 111.

An annular abutment 117 is formed at the end of the outlet tube 116. Theannular abutment 117 defines the entry to an orifice 115 through whichfluid can flow in use and is arranged for abutment with an end of thedelivery tube 131.

The fluid discharge device 108 is in most respects conventional and isas previously described herein.

The collar 140 is connected to the neck 129 of the container 130 by asnap connection in which the neck 129 has a groove 141 into which thecollar 140 is snap fitted. The collar 140 has a slit 142 in one sidethat allows it to be pushed onto the neck 129 and engage with the groove141.

The actuating means is a resilient flexible member in the form of a leafspring 176 connected to an upper end of the lever 170 so as to hold theresilient flexible member 176 in an upwardly bowed state. However, itwill be appreciated that more than one resilient flexible member couldbe used if required.

The lower end of the lever 170 is pivotally connected to the housing 109by means of a pivot pin 123.

The resilient flexible member 176 is operably connected to the neck 129of the container 130 by abutment of an upper surface of the resilientflexible member 176 against a lower surface 127 of the collar 140, whichis attached to the neck 129 of the container 130.

A stop means 125 is provided to limit rotational movement of the lever170 away from the container 130 so as to maintain the resilient flexiblemember 176 in a bowed state. The stop means 125 takes the form of oneedge of the aperture through which the lever 170 projects.

The resilient flexible member 176 is connected at one end to the upperend of the lever 170 by engagement with a groove 134 formed in the lever170 and is connected at an opposite end to part of the body structure ofthe fluid dispensing device 165 in the form of the housing 109 which hasa groove 135 formed therein with which the resilient flexible member 124is engaged.

It will be appreciated that if removed from the fluid dispensing device165 the resilient flexible member will return to a flat planar shape asit undergoes no plastic deformation during use but only elasticdeformation.

The stop 125 is positioned such that when the lever 120 is displacedfully from the container 130 so as to rest against the stop 125 thelinear distance between the upper end of the lever 120 and the positionof connection of the resilient flexible member 176 to the housing 109 isless than the un-bowed length of the resilient flexible member 176. Thisensures that the flexible member never returns to a flat shape. This isimportant because the resilient flexible member must be bowed upwardlyto function correctly and if it were to be fully released there is apossibility that upon re-applying a load to it would bow downwardly.

When the lever 120 is moved towards the container 130 so as to cause thecontainer 130 to be moved towards the nozzle 111, the radius ofcurvature of the bowed resilient flexible member 176 is reduced and thecollar 140 is moved upwardly thereby causing actuation of the pump.

Operation of the fluid dispensing device 165 is as follows.

After inserting a fluid discharge device 108 into the housing 109 thefluid dispensing device is ready for use and the lever 170 will beresting against the end stop 125.

To use the fluid dispensing device 165 a user must first grasp the fluiddispensing device 165 so that contact is made with the lever 170 and inparticular with the ribbed finger grip 146.

Provided that only a light pressure is applied to the lever 170 no fluidwill be discharged and the user is able to manoeuvre the dispensingnozzle 111 of the fluid dispensing device 165 into a body orifice suchas a nasal cavity into which fluid is required to be dispensed. This isbecause of the presence of the pre-load means and in particular becausethe tooth 150 is abutting with the rib 153.

If the user then exerts more force upon the lever 170 the arm 152 willbegin to bend and when the force applied to the lever 170 reaches apredetermined magnitude the tooth 150 is able to ride over or becomedetached from the rib 153 allow the lever 170 to move freely and theinteraction of the resilient flexible member 176 upon the collar 140will then cause the container 130 to be moved rapidly towards the nozzle111.

This causes the delivery tube 131 to be pushed into the containerthereby actuating the pump.

Upon releasing the pressure applied to the lever 170, the resilientflexible member 176 will try to assume is least deformed state and sowill urge the lever 170 back upon its stop 125 as soon as the force isremoved from the lever 170 allowing the tooth 150 to re-engage with therib 153.

The actuating procedure can then be repeated until all of the fluid inthe container has been used. However, only one or two doses of fluid arenormally administered at a time.

When the container 130 is empty a new fluid discharge device 108 isloaded into the body member 106 thereby restoring the fluid dispensingdevice 165 into a useable condition.

With particular reference to FIG. 13 there is shown a fluid dispensingdevice 205 which is in many respects similar to that described withrespect to FIG. 11 but in which two levers 220, 221 pivotally supportedat their lower ends are used to move a container 230 forming part of adischarge device 208 housed within a housing 206 by means of anactuating means in the form of a flexible member 241 which as shown isformed as a single part with the two levers 220, 221 but all three partscould be made as separate components.

The flexible member 242 is arranged to act against a collar 240connected to a neck 229 of the container 230 so that when the two leversare squeezed together the flexible member 241 urges the containertowards a nozzle 211 extending from one end of the housing 206. Themovement of the container 230 towards the nozzle 211 causes relativemovement between the container 230 and a discharge tube 231 connected toa pump housed within the container 230 thereby actuating the pump andcausing fluid to be urged out through the discharge tube 231 into anorifice 215 formed in the nozzle 211 from whence it is dispensed as finespray.

The fluid dispensing device 205 is fitted with a fifth embodiment of apre-load means in which the pre-load means is interposed between theactuating means 241 and the housing 206.

The pre-load means comprises of two detents 224, 227 formed on part ofthe actuating means and in this case on an upper surface of the flexiblemember 241 for engagement with part of the housing. As can be seen, eachof the detents 224, 227 is located such that when the levers 220, 221are in a rest position they abut lightly against an adjacent outersurface of the housing 206.

When a small force is applied to the two levers 220, 221 the pump is notactuated because the detents 224, 227 prevent the flexible member frommoving but when a force of a predetermined magnitude is applied to thelevers 220, 221 it is sufficient to cause the detents 224, 227 todisengage from the housing so as to allow the compression pump to beactuated. Because of the presence of the detents 224, 227 it is ensuredthat the container 230 is not moved until sufficient force is applied tothe levers 220, 221 to cause rapid movement of the container 230 towardsthe nozzle 211 and guarantee that an effective spray is produced.

It will be appreciated that alternatively, the pre-load means couldcomprise of at least one detent formed on part of the housing forengagement with a complementary recess formed on part of the actuatingmeans. In which case, each detent would be disengageable from itsrespective recess when the pre-determined force is applied to each leverso as to allow the compression pump to be actuated.

With reference to FIGS. 14 to 17 there is shown a fluid dispensingdevice 305 that is in many respects similar to those previouslydescribed.

The fluid dispensing device 305 comprises of a body 306 forming a nozzle311 and a housing 309. A fluid discharge device 308 is housed within thehousing 309. The fluid discharge device 308 comprises of a container 330in which is fitted a compression pump (not shown) and a discharge tube331 extending from one end of the container 330 for abutment against thenozzle 311. When the discharge tube 331 is moved into the container 330the pump is actuated and fluid is urged out of the discharge tube 331into an orifice 315 in the nozzle from whence it is emitted as a finespray.

There is provided a finger operable means in the form of two opposinglevers 320, 321 each of which is pivotally supported near a lower end ofthe housing 309 and is arranged to act upon an actuating means 322 so asto urge the container 330 towards the nozzle 311 when the two levers320, 321 are squeezed together.

The actuating means is in the form of two inclined ramps 322 each ofwhich is arranged to cooperate with a complementary inclined surface 324a formed on a respective one of the two levers 320, 321. The two ramps322 are connected to the container 330 by means of a collar 340 that isengaged with a neck 329 of the container.

Movement of the two levers 320, 321 towards each other causes theinclined surfaces 324 a to ride up the ramps 322 thereby urging thecontainer towards the nozzle 311.

The fluid dispensing device 305 is fitted with a pre-load meansinterposed between the housing 309 and the levers 320, 321.

The pre-load means comprises of a detent or step 342 formed on each sideof the housing 309 for engagement with an end face of each lever 320,321.

Movement of the levers 320, 321 is prevented by their engagement withthe steps 342 until a pre-determined force is applied to them at whichpoint the force applied is sufficient to cause the ends of the levers320, 321 to ride out of the steps 342 and permit free movement of thelevers 320, 321 towards the container 330 thereby causing actuation ofthe pump. In this way it is guaranteed that the pump will not beactuated until sufficient force is being applied to cause a rapidmovement of the discharge tube 331 into the container 330.

With reference to FIG. 18 there is shown a fluid dispensing device 405that is in many respects similar to that previously described withreference to FIGS. 14 to 17 but in which the pre-load means isinterposed between each lever 420, 421 and the respective actuatingmeans 422.

The fluid dispensing device 405 comprises of a body 406 forming a nozzle411 and a housing 409. A fluid discharge device 408 is housed within thehousing 409. The fluid discharge device 408 comprises of a container 430in which is fitted a compression pump (not shown) and a discharge tube431 extending from one end of the container 430 for abutment against thenozzle 411. When the discharge tube 431 is moved into the container 430the pump is actuated and fluid is urged out of the discharge tube 431into an orifice 415 in the nozzle from whence it is emitted as a finespray.

There is provided a finger operable means in the form of the twoopposing levers 420, 421 each of which is pivotally supported near alower end of the housing 409 by being connected together by a flexiblestrap 423 and is arranged to act upon the actuating means 422 so as tourge the container 430 towards the nozzle 411 when the two levers 420,421 are squeezed together.

The actuating means is in the form of two inclined ramps 422 each ofwhich is arranged to cooperate with a complementary curved surfaceformed on a respective one of the two levers 420, 421. The two ramps 422are connected to the container 430 by means of a collar 440, which isengaged with a neck 429 of the container 430.

Movement of the two levers 420, 421 towards each other causes the curvedportions of the levers 420, 421 to ride up the ramps 422 thereby urgingthe container 430 towards the nozzle 411.

The fluid dispensing device 405 is fitted with a pre-load meansinterposed between the actuating device 422 and the levers 420, 421.

The pre-load means comprises of a detent 424 a formed on each actuatingmeans in the form of an inclined ramp 422 for engagement with a recess446 formed in each lever 420,421.

Each of the detents 424 a is disengageable from its respectivecomplementary recess 446 when a pre-determined force is applied to therespective lever 420, 421 so as to allow the compression pump to beactuated.

Operation of the fluid dispensing device is as previously described whena user grasps the two levers 420, 421 with less than the pre-determinedforce movement of the levers 420, 421 is prevented by the engagement ofthe detents 424 a with the recesses 446 but as soon as a force equal toor greater than the pre-determined force is applied to the levers 420,421 then the detents 424 a are able to disengage or ride out of therecesses 446 and the two levers 420, 421 will move rapidly togetherthereby actuating the compression pump.

This ensures that the pump is only actuated when sufficient force isbeing applied to guarantee the production of an effective spray.

It will be appreciated that the pre-load means could alternativelycomprises of at least one detent formed on each lever for engagementwith a respective recess formed on part of the actuating means. In whichcase, each detent would be disengageable from its respectivecomplementary recess when the pre-determined force is applied to thelever so as to allow the compression pump to be actuated.

With reference to FIG. 19 there is shown a fluid dispensing device 405that is in many respects similar to that previously described withreference to FIG. 18 but in which an alternative form of pre-load meansis interposed between each lever 420, 421 and the respective actuatingmeans 422. The same reference numerals are used for like parts and theconstruction of the fluid dispensing device 405 will not be describedfurther except so far as it relates to the pre-load means.

The features of the actuating device 422 may be better understood havingregard to FIGS. 19A and 19B, which show side and perspective viewsthereof.

The pre-load means comprises of an actuating device 441 having a collar440 for receipt by neck 429 of the container 430. The actuating device441 is provided on opposing sides with ramps 422, each having a variablemechanical ratio such that until a pre-determined force is applied toeach lever 420, 421 no significant force is transferred to the container430.

This is achieved by having a first portion 425 a of each ramp 422inclined at a lesser angle (e.g. approx 20°) to a longitudinal (i.e.vertical, as shown) axis of the fluid discharge device 408 than is theremaining length 425 b (e.g. angle approx. 45°) of each ramp 422.Therefore when a force is initially applied to each lever 420, 421 it isapplied substantially normal to the longitudinal axis of the fluiddischarge device 408 and virtually no force is converted into a forcealong the longitudinal axis of the fluid discharge device 408 and so thestatic friction between the first portion 425 a of each ramp 422 and thecooperating lever 420, 421 is sufficient to maintain the levers 420, 421stationary. However, when a pre-determined load is applied to each lever420, 421 the static friction is overcome and each lever 420, 421 is ableto start moving along the first portion 425 a of the cooperating ramp422. When each lever 420, 421 reaches the end of the first portion 425a, the change in inclination of the surface with which the lever 420,421 is cooperating in combination with the magnitude of the force beingapplied ensures that each lever 420, 421 suddenly slides rapidly alongthe second portion 425 b of the cooperating ramp 422 causing thecontainer 430 to be moved rapidly towards the nozzle 411 to actuate thecompression pump.

This ensures that the pump is only actuated when sufficient force isbeing applied to guarantee the production of an effective spray.

As visible in FIGS. 19A and 19B, the actuating device 441 is alsoprovided on opposing sides of the collar 440 with guide rails 426 a,each perpendicularly arranged with respective to both ramps 422. Theguide rails 426 a interact with mating guides (not visible) on thehousing 409 to ensure uniform longitudinal movement of the container 430during actuation.

With reference to FIGS. 20 and 21 there is shown a fluid dispensingmeans that is in most respects identical to that previously describedwith respect to FIGS. 18 and 19 and for which the same referencenumerals are used for identical parts. The only difference between thefluid dispensing device 405 shown in FIGS. 20 and 21 and those shown inFIGS. 18 and 19 is the arrangement of the pre-load means, which in thiscase is interposed between each of the levers 420, 421 and the housing409. In addition, an end cap 407 is shown fitted in FIGS. 20 and 21.

The pre-load means comprises of two detents or protrusions 428 formed oneach of the levers 420, 421 for engagement with a bevelled surface 427formed around the periphery of an aperture in the housing 409 throughthe respective lever 420, 421 projects.

When a light force is applied to the two levers 420, 421 they areprevented from moving into the housing by the abutment of the detents428 with the bevelled surfaces 427. When the force applied to each lever420, 421 reaches a pre-determined magnitude it is sufficient to deflectthe side walls of the levers 420, 421 inwardly so allowing the detents428 to ride across the bevelled surfaces 427 into the housing 409. Asoon as the detents have passed over the bevelled surfaces 427 thelevers 420, 421 are free to move towards the container 430 housed withinthe housing 409 so as to actuate the pump. Once again, this ensures thata reliable spray is produced.

When the force is released from the levers 420, 421 they are moved backtowards their start positions but require the application of a smalloutward force in order to re-engage the detents 428 with the bevelledsurfaces 427.

With particular reference to FIGS. 22 to 24 there is shown a fluiddispensing device 505 having a housing 509 for housing a fluid dischargedevice 508. The housing has a nozzle 511 extending out from one end forengagement with a body orifice such as a nasal cavity.

The fluid discharge device is conventional in nature and as ispreviously described having a container 530 for the fluid to bedispensed, a compression pump fixed within the container 530 and adischarge tube 531 extending out from the pump to deliver fluid to anorifice 515 formed in the nozzle 511. As previously described the pumpis actuated by pushing the discharge tube 531 into the pump, which isachieved by moving the container 530 towards the nozzle 511.

A finger operable means is provided to move the container 530, thefinger operable means is in the form of a lever 520 slidably supportedwithin the housing 509 to apply a force to the container 530 so as tomove the container 530 towards the nozzle 511 and actuate thecompression pump.

The lever 520 has two flanges each of which is slidably supported bymeans of rails 555, 556 that are engaged with U-shaped guides 557 formedin the housing 509.

A pre-load means is provided to prevent the pump being actuated before apre-determined force is applied to the lever 520.

The pre-load means comprises of a spring 558 interposed between thelever 520 and the container 530 and a latching means 560, 561. Thespring 558 is used to urge the container 530 towards the nozzle 511 soas to actuate the compression pump.

The spring is interposed between a collar 540 connected to the container530 and a base plate 541. A transfer rod 542 extends out from each sideof the base plate for engagement with an inclined surface 543 formed oneach flange of the lever 520. When the lever 520 is pushed or urged by auser towards the container 530 the transfer rods 542 move up theinclined surfaces 543 thereby compressing the spring 558. However, thecontainer 530 is not moved because the collar 540 is connected to thehousing 509 by the latching means 560, 561.

The latching means comprises of a rib 560 formed on an internal wall ofthe housing 509 and two outwardly extending arm 561 connected to thecollar 540.

Each of the arms 561 is connected to the collar via a living hinge 563so that when the collar 540 moves towards the nozzle 511 the arms 561are able to abut against the collar 540 and so transfer load to the rib560 but when the collar 540 is moving away from the nozzle 511 the arms561 are able to flip up so as to allow them to pass freely over the rib560. A return spring 565 is provided to return the lever 520 to itsnormal rest position when no force is being applied to it.

Operation of the fluid dispensing device is as follows.

The application of an initial force to the lever 520 causes the spring558 to be compressed by the movement of the lever 520 without anymovement of the container 530 occurring due to the engagement of thearms 561 with the rib 560. This will continue until a pre-determinedforce is applied, at which point the means used to prevent actuation ofthe compression pump, that is to say the arms 561 and the rib 560, areovercome by the force being applied to the container 530 by the spring558 and the container 530 moves rapidly towards the nozzle 511 so as toactuate the compression pump.

Upon releasing the force from the lever 520 it is returned to its restposition by the return spring 565 and a spring within the pump returnsthe container back to its rest position so that the arms 561 re-engagewith the rib 560.

The use of a spring to move the container has the advantage that a knownforce is used to move the container and so a consistent spray can beproduced.

It will be appreciated that although the invention has been describedwith respect to several specific embodiments there are many alternativecombinations and arrangements that could be used. The primary objectiveof the invention is to provide a fluid dispensing device that isoperable by one or more levers applying a force to a containertransversely with respect to a longitudinal axis of the container andwhich includes some pre-load mechanism or means to prevent the containerfrom being significantly moved until the force being applied to itreaches a pre-determined magnitude known to produce a reliable highquality spray.

Administration of medicament may be indicated for the treatment of mild,moderate or severe acute or chronic symptoms or for prophylactictreatment. It will be appreciated that the precise dose administeredwill depend on the age and condition of the patient, the particularmedicament used and the frequency of administration and will ultimatelybe at the discretion of the attendant physician. Embodiments areenvisaged in which combinations of medicaments are employed.

Appropriate medicaments may thus be selected from, for example,analgesics, e.g., codeine, dihydromorphine, ergotamine, fentanyl ormorphine; anginal preparations, e.g., diltiazem; antiallergics, e.g.,cromoglycate (eg as the sodium salt), ketotifen or nedocromil (eg as thesodium salt); antiinfectives e.g., cephalosporins, penicillins,streptomycin, sulphonamides, tetracyclines and pentamidine;antihistamines, e.g., methapyrilene; anti-inflammatories, e.g.,beclomethasone (eg as the dipropionate ester), fluticasone (eg as thepropionate ester), flunisolide, budesonide, rofleponide, mometasone (egas the furoate ester), ciclesonide, triamcinolone (eg as the acetonide),6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioicacid S-(2-oxo-tetrahydro-furan-3-yl) ester or 6α,9α-Difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester; antitussives, e.g., noscapine;bronchodilators, e.g., albuterol (eg as free base or sulphate),salmeterol (eg as xinafoate), ephedrine, adrenaline, fenoterol (eg ashydrobromide), formoterol (eg as fumarate), isoprenaline,metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol (eg asacetate), reproterol (eg as hydrochloride), rimiterol, terbutaline (egas sulphate), isoetharine, tulobuterol or4-hydroxy-7-[2-[[2-[[3-(2-phenylethoxy)propyl]sulfonyl]ethyl]amino]ethyl-2(3H)-benzothiazolone;PDE4 inhibitors eg cilomilast or roflumilast; leukotriene antagonists egmontelukast, pranlukast and zafirlukast; [adenosine 2a agonists, eg2R,3R,4S,5R)-2-[6-Amino-2-(1S-hydroxymethyl-2-phenyl-ethylamino)-purin-9-yl]-5(2-ethyl-2H-tetrazol-5-yl)-tetrahydro-furan-3,4-diol(e.g. as maleate)]*; [α4 integrin inhibitors eg(2S)-3-[4-({[4-(aminocarbonyl)-1-piperidinyl]carbonyl}oxy)phenyl]-2-[((2S)-4-methyl-2-{[2-(2-methylphenoxy)acetyl]amino}pentanoyl)amino]propanoic acid (e.g as free acid orpotassium salt)]*, diuretics, e.g., amiloride; anticholinergics, e.g.,ipratropium (eg as bromide), tiotropium, atropine or oxitropium;hormones, e.g., cortisone, hydrocortisone or prednisolone; xanthines,e.g., aminophylline, choline theophyllinate, lysine theophyllinate ortheophylline; therapeutic proteins and peptides, e.g., insulin orglucagons. It will be clear to a person skilled in the art that, whereappropriate, the medicaments may be used in the form of salts, (e.g., asalkali metal or amine salts or as acid addition salts) or as esters(e.g., lower alkyl esters) or as solvates (e.g., hydrates) to optimisethe activity and/or stability of the medicament and/or to minimise thesolubility of the medicament in the propellant.

Preferably, the medicament is an anti-inflammatory compound for thetreatment of inflammatory disorders or diseases such as asthma andrhinitis.

In one aspect, the medicament is a glucocorticoid compound, which hasanti-inflammatory properties. One suitable glucocorticoid compound hasthe chemical name:6α,9α-Difluoro-17α-(1-oxopropoxy)-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester (fluticasone propionate). Another suitableglucocorticoid compound has the chemical name:6α,9α-difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester. A further suitable glucocorticoid compoundhas the chemical name:6α,9α-Difluoro-11β-hydroxy-16α-methyl-17α-[(4-methyl-1,3-thiazole-5-carbonyl)oxy]-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester.

Other suitable anti-inflammatory compounds include NSAIDs e.g. PDE4inhibitors, leukotriene antagonists, iNOS inhibitors, tryptase andelastase inhibitors, beta-2 integrin antagonists and adenosine 2aagonists.

The medicament is formulated as any suitable fluid formulation,particularly a solution (e.g. aqueous) formulation or a suspensionformulation, optionally containing other pharmaceutically acceptableadditive components.

Suitable formulations (e.g. solution or suspension) may be stabilised(e.g. using hydrochloric acid or sodium hydroxide) by appropriateselection of pH. Typically, the pH will be adjusted to between 4.5 and7.5, preferably between 5.0 and 7.0, especially around 6 to 6.5.

Suitable formulations (e.g. solution or suspension) may comprise one ormore excipients. By the term “excipient”, herein, is meant substantiallyinert materials that are nontoxic and do not interact with othercomponents of a composition in a deleterious manner including, but notlimited to, pharmaceutical grades of carbohydrates, organic andinorganic salts, polymers, amino acids, phospholipids, wetting agents,emulsifiers, surfactants, poloxamers, pluronics, and ion exchangeresins, and combinations thereof.

Suitable carbohydrates include monosaccharides include fructose;disaccharides, such as, but not limited to lactose, and combinations andderivatives thereof; polysaccharides, such as, but not limited to,cellulose and combinations and derivatives thereof; oligosaccharides,such as, but not limited to, dextrins, and combinations and derivativesthereof; polyols, such as but not limited to sorbitol, and combinationsand derivatives thereof.

Suitable organic and inorganic salts include sodium or calciumphosphates, magnesium stearate, and combinations and derivativesthereof.

Suitable polymers include natural biodegradable protein polymers,including, but not limited to, gelatin and combinations and derivativesthereof; natural biodegradable polysaccharide polymers, including, butnot limited to, chitin and starch, crosslinked starch and combinationsand derivatives thereof; semisynthetic biodegradable polymers,including, but not limited to, derivatives of chitosan; and syntheticbiodegradable polymers, including, but not limited to, polyethyleneglycols (PEG), polylactic acid (PLA), synthetic polymers including butnot limited to polyvinyl alcohol and combinations and derivativesthereof;

Suitable amino acids include non-polar amino acids, such as leucine andcombinations and derivatives thereof. Suitable phospholipids includelecithins and combinations and derivatives thereof.

Suitable wetting agents, surfactants and/or emulsifiers include gumacacia, cholesterol, fatty acids including combinations and derivativesthereof. Suitable poloxamers and/or Pluronics include poloxamer 188,Pluronic® F-108, and combinations and derivations thereof. Suitable ionexchange resins include amberlite IR120 and combinations and derivativesthereof;

Suitable solution formulations may comprise a solubilising agent such asa surfactant. Suitable surfactants includeα-[4-(1,1,3,3-tetramethylbutyl)phenyl]<-hydroxypoly(oxy-1,2-ethanediyl)polymers including those of the Triton series e.g. Triton X-100, TritonX-114 and Triton X-305 in which the X number is broadly indicative ofthe average number of ethoxy repeating units in the polymer (typicallyaround 7-70, particularly around 7-30 especially around 7-10) and4-(1,1,3,3-tetramethylbutyl)phenol polymers with formaldehyde andoxirane such as those having a relative molecular weight of 3500-5000especially 4000-4700, particularly Tyloxapol. The surfactant istypically employed in a concentration of around 0.5-10%, preferablyaround 2-5% w/w based on weight of formulation.

Suitable solution formulations may also comprise hydroxyl containingorganic co-solvating agents include glycols such as polyethylene glycols(eg PEG 200) and propylene glycol; sugars such as dextrose; and ethanol.Dextrose and polyethylene glycol (eg PEG 200) are preferred,particularly dextrose. Propylene glycol is preferably used in an amountof no more than 20%, especially no more than 10% and is most preferablyavoided altogether. Ethanol is preferably avoided. The hydroxylcontaining organic co-solvating agents are typically employed at aconcentration of 0.1-20% e.g. 0.5-10%, e.g. around 1-5% w/w based onweight of formulation.

Suitable solution formulations may also comprise solublising agents suchas polysorbate, glycerine, benzyl alcohol, polyoxyethylene castor oilsderivatives, polyethylene glycol and polyoxyethylene alkyl ethers (e.g.Cremophors, Brij).

Suitable solution formulations may also comprise one or more of thefollowing components: viscosity enhancing agents; preservatives; andisotonicity adjusting agents.

Suitable viscosity enhancing agents include carboxymethylcellulose,veegum, tragacanth, bentonite, hydroxypropylmethylcellulose,hydroxypropylcellulose, hydroxyethylcellulose, poloxamers (eg. poloxamer407), polyethylene glycols, alginates xanthym gums, carageenans andcarbopols.

Suitable preservatives include quaternary ammonium compounds (e.g.benzalkonium chloride, benzethonium chloride, cetrimide andcetylpyridinium chloride), mercurial agents (e.g. phenylmercuricnitrate, phenylmercuric acetate and thimerosal), alcoholic agents (e.g.chlorobutanol, phenylethyl alcohol and benzyl alcohol), antibacterialesters (e.g. esters of para-hydroxybenzoic acid), chelating agents suchas disodium edetate (EDTA) and other anti-microbial agents such aschlorhexidine, chlorocresol, sorbic acid and its salts and polymyxin.

Suitable isotonicity adjusting agents act such as to achieve isotonicitywith body fluids (e.g. fluids of the nasal cavity), resulting in reducedlevels of irritancy associated with many nasal formulations. Examples ofsuitable isotonicity adjusting agents are sodium chloride, dextrose andcalcium chloride.

Suitable suspension formulations comprise an aqueous suspension ofparticulate medicament and optionally suspending agents, preservatives,wetting agents or isotonicity adjusting agents.

The particulate medicament suitably has a mass mean diameter (MMD) ofless than 20 μm, preferably between 0.5-10 μm, especially between 1-5μm. If particle size reduction is necessary, this may be achieved bytechniques such as micronisation and/or microfluidisation.

Suitable suspending agents include carboxymethylcellulose, veegum,tragacanth, bentonite, methylcellulose and polyethylene glycols.

Suitable wetting agents function to wet the particles of medicament tofacilitate dispersion thereof in the aqueous phase of the composition.Examples of wetting agents that can be used are fatty alcohols, estersand ethers. Preferably, the wetting agent is a hydrophilic, non-ionicsurfactant, most preferably polyoxyethylene (20) sorbitan monooleate(supplied as the branded product Polysorbate 80).

Suitable preservatives and isotonicity adjusting agents are as describedabove in relation to solution formulations.

The dispensing device herein is suitable for dispensing fluid medicamentformulations for the treatment of inflammatory and/or allergicconditions of the nasal passages such as rhinitis e.g. seasonal andperennial rhinitis as well as other local inflammatory conditions suchas asthma, COPD and dermatitis.

A suitable dosing regime would be for the patient to inhale slowlythrough the nose subsequent to the nasal cavity being cleared. Duringinhalation the formulation would be applied to one nostril while theother is manually compressed. This procedure would then be repeated forthe other nostril. Typically, one or two inhalations per nostril wouldbe administered by the above procedure up to three times each day,ideally once daily. Each dose, for example, may deliver 5 μg, 50 μg, 100μg, 200 μg or 250 μg of active medicament. The precise dosage is eitherknown or readily ascertainable by those skilled in the art.

The application of which this description and claims form part may beused as a basis for priority in respect of any subsequent application.The claims of such subsequent application may be directed to any featureor combination of features described therein. They may take the form ofproduct, method or use claims and may include, by way of example andwithout limitation, one or more of the following claims.

1. A fluid dispensing device for spraying a fluid into a body cavitycomprising a housing, a nozzle for insertion into a body cavity, a fluiddischarge device moveably housed within the housing, the fluid dischargedevice having a longitudinal axis and comprising a container for storingthe fluid to be dispensed and a compression pump having a suction inletlocated within the container and a discharge tube extending along thelongitudinal axis for transferring fluid from the pump to the nozzle andfinger operable means moveable transversely with respect to thelongitudinal axis of the fluid discharge device to apply a force to thecontainer to move the container along the longitudinal axis towards thenozzle so as to actuate the compression pump wherein a pre-load means isprovided to prevent actuation of the compression pump until apre-determined force is applied to the finger operable means.
 2. A fluiddispensing device as claimed in claim 1 in which the finger operablemeans comprises of at least one lever pivotally connected to part of thehousing and arranged to act upon the container so as to urge thecontainer towards the nozzle when the or each lever is moved by a user.3. A fluid dispensing device as claimed in claim 2 in which there aretwo opposing levers, each of which is pivotally connected to part of thehousing and is arranged to act upon the container so as to urge thecontainer towards the nozzle when the two levers are squeezed togetherby a user.
 4. A fluid dispensing device as claimed in claim 1 in whichthe finger operable means comprises at least one lever to apply a forceto an actuating means used to move the container towards the nozzle soas to actuate the pump.
 5. A fluid dispensing device as claimed in claim4 in which the or each lever is pivotally supported at a lower endwithin the housing and the actuating means is connected to a neck of thecontainer.
 6. A fluid dispensing device as claimed in claim 5 in whichthere are two opposing levers, each of which is pivotally supported neara lower end of the housing and is arranged to act upon the actuatingmeans so as to urge the container towards the nozzle when the two leversare squeezed together by a user.
 7. A fluid dispensing device as claimedin claim 1 in which the finger operable means comprises of at least onelever slidably supported within the housing to apply a force to thecontainer so as to move the container towards the nozzle and actuate thecompression pump.
 8. A fluid dispensing device as claimed in claim 1 inwhich the pre-load means is interposed between the finger operable meansand the container.
 9. A fluid dispensing device as claimed in claim 8 inwhich the pre-load means comprises of a step formed on the containerwhich must be ridden over by the finger operable means before thecompression pump can be actuated wherein the step is over-ridden whenthe pre-determined force is applied to the finger operable means.
 10. Afluid dispensing device as claimed in claim 8 in which the pre-loadmeans comprises of a step formed on the finger operable means which mustbe ridden over by the container before the compression pump can beactuated wherein the step is over-ridden when the pre-determined forceis applied to the finger operable means.
 11. A fluid dispensing deviceas claimed in claim 8 in which the pre-load means comprises of at leastone detent formed on one of the container or the finger operable meansand a recess formed on the other of the container or the finger operablemeans wherein the or each detent is able to ride out of the recess withwhich it is engaged when the pre-determined force is applied to thefinger operable means.
 12. A fluid dispensing device as claimed in claim1 in which the pre-load means is interposed between the housing and thecontainer.
 13. A fluid dispensing device as claimed in claim 12 in whichthe pre-load means comprises of one or more detents formed on thecontainer for engagement with part of the housing, the or all of thedetents being disengageable from the housing when the pre-determinedforce is applied to the finger operable means so as to allow thecompression pump to be actuated.
 14. A fluid dispensing device asclaimed in claim 12 in which the pre-load means comprises of one or moredetents formed on the housing for engagement with part of the container,the or all of the detents being disengageable from the container whenthe pre-determined force is applied to the finger operable means so asto allow the compression pump to be actuated.
 15. A fluid dispensingdevice as claimed in claim 1 in which the pre-load means is interposedbetween the container and the discharge tube.
 16. A fluid dispensingdevice as claimed in claim 15 in which the pre-load means comprises of astep formed on the discharge tube and at least one latching memberattached to the container, the arrangement being such that, when thepre-determined force is applied to the finger operable means, the oreach latching member is able to ride over the step so as to allow thecompression pump to be actuated.
 17. A fluid dispensing device asclaimed in claim 15 in which the pre-load means comprises of a recessformed on the discharge tube and at least one latching member attachedto the container, the arrangement being such that, when thepre-determined force is applied to the finger operable means, the oreach latching member is able to ride out of the recess so as to allowthe compression pump to be actuated.
 18. A fluid dispensing device asclaimed in claim 1 in which the pre-load means is interposed between thehousing and the finger operable means.
 19. A fluid dispensing device asclaimed in claim 18 in which the pre-load means comprises of at leastone detent formed on the housing for engagement with the finger operablemeans, the or all of the detents being disengageable from the fingeroperable means when the pre-determined force is applied to the fingeroperable means so as to allow the compression pump to be actuated.
 20. Afluid dispensing device as claimed in claim 18 in which the pre-loadmeans comprises of at least one detent formed on the finger operablemeans for engagement with part of the housing, the or all of the detentsbeing disengageable from the housing when the pre-determined force isapplied to the finger operable means so as to allow the compression pumpto be actuated.
 21. A fluid dispensing device as claimed in claim 4 inwhich the pre-load means is interposed between the actuating means andthe housing.
 22. A fluid dispensing device as claimed in claim 21 inwhich the pre-load means comprises of at least one detent formed on partof the actuating means for engagement with part of the housing, the orall of the detents being disengageable from the housing when thepre-determined force is applied to the finger operable means so as toallow the compression pump to be actuated.
 23. A fluid dispensing deviceas claimed in claim 21 in which the pre-load means comprises of at leastone detent formed on part of the housing each detent being arranged forengagement with a complementary recess formed on part of the actuatingmeans, each detent being disengageable from its respective recess whenthe pre-determined force is applied to the finger operable means so asto allow the compression pump to be actuated.
 24. A fluid dispensingdevice as claimed in claim 4 in which the pre-load means is interposedbetween the finger operable means and the respective actuating means.25. A fluid dispensing device as claimed in claim 24 in which thepre-load means comprises of at least one detent formed on each lever forengagement with a respective recess formed on part of the actuatingmeans, each detent being disengageable from its respective complementaryrecess when the pre-determined force is applied to the lever so as toallow the compression pump to be actuated.
 26. A fluid dispensing deviceas claimed in claim 24 in which the pre-load means comprises of at leastone detent formed on each actuating means for engagement with a recessformed on a respective finger operable means, each detent beingdisengageable from its respective complementary recess when thepre-determined force is applied to the finger operable means so as toallow the compression pump to be actuated.
 27. A fluid dispensing deviceas claimed in claim 24 in which the pre-load means comprises of anactuating device having a variable mechanical ratio such that until thepre-determined force is applied to the or each lever no significantforce is transferred to the container along the longitudinal axis.
 28. Afluid dispensing device as claimed in claim 12 in which the fingeroperable means comprises of a single lever and the pre-load meansfurther comprises of a spring interposed between the lever and thecontainer, the spring being used to urge the container towards thenozzle so as to actuate the compression pump.
 29. A fluid dispensingdevice as claimed in claim 28 in which the spring is compressed bymovement of the lever until the pre-determined force is applied, atwhich point the means used to prevent actuation of the compression pumpare overcome by the force being applied to the container by the springand the container moves rapidly towards the nozzle so as to actuate thecompression pump.
 30. A fluid dispensing device as claimed in claim 1additionally comprising force modifying means for modifying the forceapplied to the container by the finger operable means.
 31. A fluiddispensing device as claimed in claim 30 in which said force modifyingmeans amplifies the force applied to the container by the fingeroperable means.
 32. A fluid dispensing device as claimed in claim 31 inwhich the amplification is provided in a uniform manner.
 33. A fluiddispensing device as claimed in claim 32 in which the degree ofamplification is from 1.5 to
 10. 34. A fluid dispensing device asclaimed in claim 30 in which the force modifying means is integral withthe finger operable means.
 35. A fluid dispensing device as claimed inclaim 30 in which the force modifying means is located between thefinger operable means and the container.
 36. A fluid dispensing deviceas claimed in claim 30 in which the force modifying means comprises alever, cam or screw element.
 37. A fluid dispensing device as claimed inclaim 30 in which the force modifying means acts once the pre-determinedforce has been applied to the finger operable means.
 38. A fluiddispensing device as claimed in claim 37 in which the force modifyingmeans acts such that once the pre-determined force has been applied tothe finger operable means the modified force applied to the container isrelatively constant.
 39. A fluid dispensing device as claimed in claim37 in which the force modifying means acts such that once thepre-determined force has been applied to the finger operable means themodified force applied to the container increases on a relativelyconstant basis.
 40. A fluid dispensing device as claimed in claim 30 inwhich the force modifying means additionally comprises a stop element.41. A fluid dispensing device as claimed in claim 1 wherein saidcontainer contains a volume of fluid medicament formulation.
 42. A fluiddispensing device as claimed in claim 41, wherein said fluid medicamentformulation is in the form of a solution formulation.
 43. A fluiddispensing device as claimed in claim 41, wherein said fluid medicamentformulation is in the form of a suspension formulation.
 44. A fluiddispensing device as claimed in claim 41, wherein the fluid medicamentformulation comprises an anti-inflammatory medicament compound.
 45. Afluid dispensing device as claimed in claim 44, wherein said medicamentcompound is a glucocorticoid compound.
 46. A fluid dispensing device asclaimed in claim 45, wherein said glucocorticoid compound is selectedfrom the group consisting of6α,9α-Difluoro-17α-(1-oxopropoxy)-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester;6α,9α-difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester; and6α,9α-Difluoro-11β-hydroxy-16α-methyl-17α-[(4-methyl-1,3-thiazole-5-carbonyl)oxy]-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester.
 47. A fluid dispensing device as claimed inclaim 44, wherein said medicament compound is selected from the groupconsisting of PDE4 inhibitors, leukotriene antagonists, iNOS inhibitors,tryptase and elastase inhibitors, beta-2 integrin antagonists andadenosine 2a agonists.
 48. A housing assembly for reversible receipt ofa fluid discharge device for spraying a fluid into a body cavity, saidfluid discharge device having a longitudinal axis and comprising acontainer for storing the fluid to be dispensed and a compression pumphaving a suction inlet located within the container and a discharge tubeextending along the longitudinal axis for transferring fluid from thepump to the nozzle, the housing assembly comprising a housing, a nozzlefor insertion into a body cavity and finger operable means moveabletransversely with respect to the longitudinal axis of the fluiddischarge device to apply a force to the container to move the containeralong the longitudinal axis towards the nozzle so as to actuate thecompression pump wherein a pre-load means is provided to preventactuation of the compression pump until a pre-determined force isapplied to the finger operable means.
 49. Kit of parts comprising ahousing assembly as claimed in claim 48 and a fluid discharge devicehaving a longitudinal axis and comprising a container for storing thefluid to be dispensed and a compression pump having a suction inletlocated within the container and a discharge tube extending along thelongitudinal axis for transferring fluid from the pump to the nozzle.50-51. (canceled)